Moderate to Severe Plaque PsoriasisPhase 1NCT05258331
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis
A Phase 1 study testing CT303 in people with Moderate to Severe Plaque Psoriasis, run by GC Cell Corporation at 3 sites in South Korea.
Trial summary
Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- CT303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 25 Oct 2021to 30 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 19 years old
- Plaque psoriasis diagnosed before ≥ 6 months who did not show a sufficient response to one or more of the traditional systemic treatments or require change of treatment due to intolerance
- Have moderate to severe plaque psoriasis as defined by PASI score ≥ 12, BSA ≥ 10% and sPGA score ≥ 3
- Patients who have voluntarily decided to participate in the study and signed the informed consent form
Who cannot join
- Guttate psoriasis, erythrodermic psoriasis, palmoplantar psoriasis, drug-induced psoriasis, and inverse psoriasis
- History of treatment with cell therapy products including but not limited to mesenchymal stem cells
- Have hypersensitivity, or medical history of clinically significant hypersensitivity, to the IP or its excipients
- Current or history of cardiovascular diseases
- Clinically significant hemorrhagic diseases, or gastrointestinal, respiratory, endocrinal, musculoskeletal, or neuropsychiatric disorders that are deemed by the investigator to be a potential threat to the safety of the subject due to study participation
- Use of anticoagulants within 7 days prior to IP administration
Show all 24Show fewer
- Following treatment history for psoriasis
- Use of topical therapy within the past 2 weeks
- Use of phototherapy and/or systemic therapy within the past 4 weeks
- Use of biologics within the past 4 to 24 weeks
- Severe infection or other uncontrolled active infectious diseases requiring administration of systemic antibiotics, antivirals, etc. within 4 weeks prior to IP administration
- Systemic or local inflammatory diseases requiring systemic anti-inflammatory treatment within 4 weeks prior to IP administration
- Received or are scheduled to receive a live/live attenuated viral/bacterial vaccination within 12 weeks prior to IP administration (within 12 months for BCG vaccines)
- Require administration of any prohibited concomitant medication specified in this protocol during participation in the study
- QTc interval > 480 msec
- Any of the following abnormalities or abnormal findings from laboratory tests:
- AST or ALT > 3 times the upper limit of normal
- Serum creatinine > 1.5 times the upper limit of normal
- ANC < 1,500/μL, Hemoglobin < 10 g/dL, Platelet count < 100,000/μL
- Hepatitis B or C infection or positive test for HIV at screening
- History of malignant tumors within the last 5 years prior
- Received or used any other IP or investigational device within 4 weeks prior to IP administration
- Pregnant or breast-feeding women, or women of childbearing potential and men who do not agree to abstinence or use of effective methods of contraception from the time of obtaining informed consent and during the study
- Patients who are deemed ineligible to participate in the study for other reasons by the investigator
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
CHA Medical School Bundang CHA Medical Center
Gyeonggi-do, 13496
Donghyun Kim, terios92@hanmail.net
Donghyun Kim
- Recruiting
Pusan national university hospital
Pusan, 49241
Byungsoo Kim, dockbs@pusan.ac.kr
Byungsoo Kim
- Recruiting
Seoul national university hospital
Seoul, 03080
Seongjin Jo, sj.jo@snu.ac.kr
Seongjin Jo
About this study
Official title: An Open-label, Dose-escalation, Phase 1 Trial to Investigate the Safety, Tolerability, and Efficacy After Single- and Multiple-dose Administration of CT303 in Patients With Moderate to Severe Plaque Psoriasis
Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis
Read the detailed description
This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. The primary purpose is to evaluate the safety and tolerability of CT303 and the secondary purpose is to evaluate the safety and efficacy of CT303 in patients with moderate to severe plaque psoriasis.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- CT303
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT303Genetic
- Cohort 1 : Single-dose administration, intravenous injection
- Dose 1(Starting dose) : 1.0*10^6 cells/kg
- Dose 2 : 2.0*10^6 cells/kg
- Dose 3 : 3.0*10^6 cells/kg
- Cohort 2 : Multiple-dose administration, intravenous injections (Week 0, Week 4)
- Dose 1(Starting dose) : 1.0*10^6 cells/kg
- Dose 2 : 2.0*10^6 cells/kg
- Dose 3 : 3.0*10^6 cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | CT303 Receives: Genetic: CT303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE (treatment-emergent adverse event) incidence rate
Evaluate safety through the incidence rate of TEAE (treatment-emergent adverse event) after CT303 administration
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start25 Oct 2021
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seongjin Jo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258331
- Sponsor's protocol ID
- CT303A101
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation, Phase 1 Trial to Investigate the Safety, Tolerability, and Efficacy After Single- and Multiple-dose Administration of CT303 in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05258331
- Acronym / sponsor ID
- CT303A101
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis
Detailed description
This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. The primary purpose is to evaluate the safety and tolerability of CT303 and the secondary purpose is to evaluate the safety and efficacy of CT303 in patients with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Genetic: CT303CT303 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 19 years old
- Plaque psoriasis diagnosed before ≥ 6 months who did not show a sufficient response to one or more of the traditional systemic treatments or require change of treatment due to intolerance
- Have moderate to severe plaque psoriasis as defined by PASI score ≥ 12, BSA ≥ 10% and sPGA score ≥ 3
- Patients who have voluntarily decided to participate in the study and signed the informed consent form
Key exclusion criteria (24 listed)
- Guttate psoriasis, erythrodermic psoriasis, palmoplantar psoriasis, drug-induced psoriasis, and inverse psoriasis
- History of treatment with cell therapy products including but not limited to mesenchymal stem cells
- Have hypersensitivity, or medical history of clinically significant hypersensitivity, to the IP or its excipients
- Current or history of cardiovascular diseases
- Clinically significant hemorrhagic diseases, or gastrointestinal, respiratory, endocrinal, musculoskeletal, or neuropsychiatric disorders that are deemed by the investigator to be a potential threat to the safety of the subject due to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT3031. Cohort 1 : Single-dose administration, intravenous injection * Dose 1(Starting dose) : 1.0*10^6 cells/kg * Dose 2 : 2.0*10^6 cells/kg * Dose 3 : 3.0*10^6 cells/kg 2. Cohort 2 : Multiple-dose administration, intravenous injections (Week 0, Week 4) * Dose 1(Starting dose) : 1.0*10^6 cells/kg * Dose 2 : 2.0*10^6 cells/kg * Dose 3 : 3.0*10^6 cells/kg | Genetic | Single Arm |
Primary outcome
TEAE (treatment-emergent adverse event) incidence rate
Time frame: Day 0 to Day 28
Evaluate safety through the incidence rate of TEAE (treatment-emergent adverse event) after CT303 administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seongjin Jo principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT303 in people with Moderate to Severe Plaque Psoriasis, run by GC Cell Corporation at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soyeon Bae (+82-31-280-9972, sybae@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAE (treatment-emergent adverse event) incidence rate (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.